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EC number: 204-881-4 | CAS number: 128-37-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non-GLP, acceptable, well-documented publication of a multicentre study with 11454 allergic contact dermatitis patients, which meets basic scientific principles. Patch test data and data from patients's history were collected from the 24 departments participating in the Information Network of Departments of dermatology from 1 january 1990 to 31 december 1994.
Data source
Reference
- Reference Type:
- publication
- Title:
- Patch testing with preservatives, antimicrobials and industrial biocides. Results from a multicentre study
- Author:
- Schnuch A et al.
- Year:
- 1 998
- Bibliographic source:
- British Journal of Dermatology 138, 467-476
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Patch-tests were performed according to recommendations of the International Contact Dermatitis Research Group and the German contact Dermatitis Group.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- human patch test: multicentre study with 11454 allergic contact dermatitis patients, which meets basic scientific principles
Test material
- Reference substance name:
- 2,6-di-tert-butyl-p-cresol
- EC Number:
- 204-881-4
- EC Name:
- 2,6-di-tert-butyl-p-cresol
- Cas Number:
- 128-37-0
- Molecular formula:
- C15H24O
- IUPAC Name:
- 2,6-di-tert-butyl-4-methylphenol
- Details on test material:
- IUCLID4 Test substance: other TS: 2 % in petrolatum
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
Challengeopen allclose all
- Route:
- other: patch-tests with allergic contact dermatitis patients, see text field results
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
- No. of animals per dose:
- 11454 patients
- Details on study design:
- see text field results
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2 %
- No. with + reactions:
- 11
- Total no. in group:
- 11 454
- Clinical observations:
- positive reaction
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 2 %. No with. + reactions: 11.0. Total no. in groups: 11454.0. Clinical observations: positive reaction.
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2 %
- No. with + reactions:
- 51
- Total no. in group:
- 11 454
- Clinical observations:
- questionable/irritative response
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 2 %. No with. + reactions: 51.0. Total no. in groups: 11454.0. Clinical observations: questionable/irritative response.
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Remarks:
- Human patch test
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- Human patch test
Any other information on results incl. tables
Patch testing:
Nine of 24 centres applied patch tests for 24 h, the remainder (15 of 24) for 48 h. Readings were done until at least 72 h after application of the test chambers. For this study only readings at 72 h were considered.
11/11454 patients showed a positive reaction with BHT;
51/11454 showed a questionable/irritative response.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In the patch test 11/11454 patients showed a positive reaction with BHT and 51/11454 patients showed a questionable/irritative response. BHT was assessed as negative in the patch test with 11454 patients (Schnuch, 1998).
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